(60 days)
Synapse 3D Base Tools is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, and treatment planning. Synapse 3D Base Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, CR, US, NM, PT, and XA, etc.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Synapse 3D Base Tools provides several levels of tools to the user:
- Basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal / oblique / curved Multi-Pianar Reconstructions (MPR), Maximum (MIP), Average (RaySum) and Minimum (MinIP) Intensity Projection, 4D volume viewing, image fusion, image subtraction, surface rendering, sector and rectangular shape MPR image viewing, MPR for dental images, creating and displaying multiple MPR images along an object, time-density distribution, basic image processing, CINE, measurements, annotations, reporting, printing, storing, distribution, and general image management and administration tools, etc.
- Tools for regional segmentation of anatomical structures within the image data, path definition through vascular and other tubular structures, and boundary detection.
- Image viewing tools for modality specific images, including CT PET fusion and ADC image viewing for MR studies.
The SYNAPSE 3D Base Tools software is medical application software running on Windows Server 2008 installed on commercial general-purpose Windows-compatible computers. SYNAPSE 3D Basic Tools software is connected through DICOM standard to other medical devices such as CT, MR, CR, US, NM, PT, XA, etc. and to PACS systems storing data generated by these medical devices. Image data obtained from these devices are used for display, image processing, analysis, etc. SYNAPSE 3D Base Tools cannot be used to interpret Mammography images.
SYNAPSE 3D Base Tools can be integrated with Synapse Workstation (cleared by CDRH via K051553 on 07/07/2005) and can be used as a part of a SYNAPSE system.
SYNAPSE 3 D Base Tools Version 3.0 expands upon the applications listed in Synapse 3D Basic Tools, #K101662 with the addition of the below new applications. In addition, new and improved algorithms are listed in Section 11.1.4.
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Slicer
Slicer creates multiple cross-sectional images along an object such as spine with MPR processing using CT or MR data. The user can adjust the location of reference lines manually to obtain desired slices. -
Combination
Combination can concatenate separated series data acquired for a single body into one single series. -
Dental MPR
Dental MPR creates a cross-sectional image along the specified line on teeth with MPR, including CPR, processing using head CT data. -
ADC Viewer
ADC Viewer accepts MR diffused weighted images, calculates ADC (Apparent Diffusion Coefficients) and EADC (Exponential ADC) values for each pixel using the known equations, and displays color mapped ADC and EADC images.
The provided text describes the Synapse 3D Base Tools device and its regulatory clearance but does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and a definitive study proving the device meets them.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states: "Pass/Fail criteria were based on the requirements and intended use of the product. Test results showed that all tests successfully passed." However, it does not provide a detailed table of these criteria nor specific quantitative performance metrics like sensitivity, specificity, or accuracy. It only generically mentions "system level functionality test, segmentation accuracy test, measurement accuracy test, interfacing test, usability test, serviceability test, as well as the test for risk mitigation method."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The document refers to "trained medical professionals" as the intended users of the tools, but not as part of a formal ground truth establishment process for testing.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC study is not explicitly mentioned or described. The document focuses on the device's functional and performance testing in isolation, rather than its comparative effectiveness with or without human readers.
6. Standalone Performance Study
The document describes "system level functionality test, segmentation accuracy test, measurement accuracy test, interfacing test, usability test, serviceability test," which implies standalone testing of the algorithm's performance on various tasks (segmentation, measurement). However, specific metrics (e.g., accuracy percentages, dice scores) are not reported.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly stated. It can be inferred that for "segmentation accuracy" and "measurement accuracy," some form of reference standard (e.g., manual segmentation by experts, known physical measurements) would have been used.
8. Sample Size for the Training Set
This information is not provided in the document. The document mentions "new and improved algorithms" but does not detail any machine learning model training or the dataset used.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document.
Summary based on available information:
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and confirming that internal testing (verification, validation) against predefined requirements was successful. It states that "Pass/Fail criteria were based on the requirements and intended use of the product. Test results showed that all tests successfully passed." However, it lacks the granular detail about the specific acceptance criteria, test methodologies, sample sizes, expert involvement, and quantitative results that your request outlines. This level of detail is typically found in the full submission or predicate device documentation, not usually in the brief 510(k) summary filed with the FDA.
Therefore, while the device "meets the acceptance criteria" as stated by the submitter, the document does not provide the specific study details nor the acceptance criteria themselves that would allow for a comprehensive answer to your questions.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).